Indications and uses
temporarily relieves • nasal congestion due to a cold, hay fever, or other upper respiratory allergies • sinus congestion and pressure
Topco Associates LLC. Sinus Nasal Spray Severe Drug Facts
- Manufacturer
- Topco Associates LLC
- Effective date
- 2024-11-07
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 00:37:35
Label at a glance#
Producttopcare sinus nasal
Active ingredientOXYMETAZOLINE HYDROCHLORIDE
Label structure9 sections
Dosage and administration
Shake well before use. Hold white tabs, SQUEEZE grooved area of cap FIRMLY and turn counter clockwise. Before using for the first time, prime the pump by firmly depressing its rim several times. Hold container with thumb at base and nozzle between first and second fingers. Without tilting your head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and inhale deeply. Secure cap after use. adul...
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient
Oxymetazoline HCl 0.05%
Purpose
Nasal decongestant
Uses
temporarily relieves
- nasal congestion due to a cold, hay fever, or other upper respiratory allergies
- sinus congestion and pressure
Warnings
Ask a doctor before use if you have
- heart disease
- thyroid disease
- diabetes
- high blood pressure
- trouble urinating due to an enlarged prostate gland
When using this product
- do not exceed recommended dosage
- do not use this product for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.
- temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur
- use of this container by more than one person may spread infection
Stop use and ask a doctor if
symptoms persist
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Directions
Shake well before use. Hold white tabs, SQUEEZE grooved area of cap FIRMLY and turn counter clockwise. Before using for the first time, prime the pump by firmly depressing its rim several times. Hold container with thumb at base and nozzle between first and second fingers. Without tilting your head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and inhale deeply. Secure cap after use.
adults & children 6 yrs. & older (with adult supervision) | 2 or 3 sprays in each nostril, not more often than every 10 to 12 hours. Do not exceed 2 doses in 24 hours. |
children 2 to under 6 yrs. | ask a doctor |
children under 2 yrs. | do not use |
Other information
- store at 20-25°C (68-77°F)
Inactive ingredients
benzalkonium chloride solution, benzyl alcohol, camphor, dibasic sodium phosphate, edetate disodium, eucalyptol, menthol, microcrystalline cellulose and carboxymethylcellulose sodium, monobasic sodium phosphate, polyethylene glycol, povidone, propylene glycol, purified water
Questions or comments?
1-888-423-0139
Package/Label Principal Display Panel
TopCare® health
COMPARE TO SINEX® SEVERE ACTIVE INGREDIENT
Sinus Nasal Spray
SEVERE
NASAL DECONGESTANT
OXYMETAZOLINE HCl 0.05%
WITH MENTHOL
ULTRA FINE MIST
12 HOUR RELIEF
• Sinus Congestion & Pressure
• Fast & Powerful Relief
1 FL OZ (30 mL)
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| OXYMETAZOLINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e67be450-f8e4-4bc1-88bd-1259d379f55f | Product name | 1 | 20210127 |
| c53f3286-4062-4cf5-8355-399519c639a6 | Product name | 1 | 20170424 |
| a993dfc5-f219-4460-bde6-30dd724d9ef0 | Product name | 1 | 20160818 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 36800-711-10 | topcare sinus nasal | 1 in 1 CARTON | SPRAY | 1 | 4 | |
| 36800-711-10 | topcare sinus nasal | 30 mL in 1 BOTTLE, SPRAY | SPRAY | 30 | 4 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- topcare sinus nasal
- Oxymetazoline hydrochloride
- OXYMETAZOLINE
- BENZALKONIUM CHLORIDE
- BENZYL ALCOHOL
- SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM
- EDETATE DISODIUM
- EUCALYPTOL
- MENTHOL, UNSPECIFIED FORM
- MICROCRYSTALLINE CELLULOSE
- CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED
- SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POVIDONE, UNSPECIFIED
- PROPYLENE GLYCOL
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 36800-711 | 36800-711-10 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| topcare sinus nasal | OXYMETAZOLINE HYDROCHLORIDE | Topco Associates LLC | ca1fefed-e9d7-430a-9da4-972b1a6fb786 | 2024-11-07 | Warnings | 36800-711-10 36800-711 36800071110 367ed4b7-2ee9-44c3-996b-b67c37278ba0 ca1fefed-e9d7-430a-9da4-972b1a6fb786 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.